Deviation Investigator

Thermo Fisher Scientific • St. Louis, MO

19h • Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Discover Impactful Work: Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.

Requirements

• Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
• Experience with quality management systems and documentation (TrackWise, Master Control, or equivalent)
• Experience in deviation investigations, CAPA, change control, and root cause analysis
• Proficient in Microsoft Office suite and quality management software systems
• Technical writing and documentation skills
• Analytical and problem-solving abilities
• Clear verbal and written communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Project management and organizational skills
• Ability to work in cleanroom environments and follow gowning procedures where required
• Must be legally authorized to work in the United States now and in the future, without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

• Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
• Additional language skills may be beneficial

Responsibilities

• Ensure compliance with GMP standards, FDA regulations, and international quality requirements
• Support manufacturing operations across multiple product lines
• Implement continuous improvement initiatives
• Conduct investigations
• Maintain quality management systems
• Conduct internal audits
• Support external regulatory inspections

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• A range of employee benefits
• Employment with an innovative, forward-thinking organization
• Outstanding career and development prospects
• An exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees